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Description of key information

Repeated dose toxicity: oral: Key study: For female rats the NOEL was 250 mg / kg bw/day. For male rats, the NOEL could not be determined (it was lower than 62.5 mg/kg bw/day). Test method was according to OECD guideline 407 and GLP.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
62.5 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

Repeated dose toxicity: oral:

Key study: Experimental results: Test method was according to OECD guideline 407 and GLP. For female rats the NOEL was 250 mg / kg bw/day. For male rats, the NOEL could not be determined (it was lower than 62.5 mg/kg bw/day).

Female animals from dose groups of 62.5 and 250 mg / kg bw/day did not show toxic effects.

In all dose groups of male rats deposits of the test substance in the epithelium of the proximal renal tubules associated with necrosis of single cells have been observed. These effects seem to be specific for male rats and contingent upon alpha-2 microglobinemia. The renal toxic effects found in all dose levels groups in male rats are interpreted as uniquely specific for male rats, and as having no relevance for other animal species and humans.

Justification for classification or non-classification

Based on these results, the substance is not classified.